Gupta Sunil, Gupta Kavita, Ravi R, Mehta Vinita, Banerjee Samar, Joshi Shashank, Saboo Banshi
Department of Diabetes and Metabolism, Sunil's Diabetes Care n' Research Centre Pvt. Ltd., Nagpur, Maharashtra, India.
Department of Dietetics, Sunil's Diabetes Care n' Research Centre Pvt. Ltd., Nagpur, Maharashtra, India.
Indian J Endocrinol Metab. 2015 Sep-Oct;19(5):639-43. doi: 10.4103/2230-8210.163187.
To determine whether pioglitazone is associated with an increased risk of bladder cancer among Indian type 2 diabetic patients.
A retrospective data analysis of 2222 type 2 diabetic patients was conducted. The study subjects were divided into two equal groups: 1111 pioglitazone users and 1111 pioglitazone non-users. The safety of pioglitazone therapy was analyzed in terms of occurrence of bladder and other types of cancers along with its efficacy in terms of glycemic control. Parameters for assessing safety were duration of disease, duration of usage and total dose of pioglitazone consumed across age groups, glycemic control, obesity and family history of any cancer. Bladder cancer prevalence was analyzed on the basis of urinary cytology, urine routine and microscopy, hematuria, urinary nuclear matrix protein 22 analysis and ultrasonography.
Of the 2222 cases analysed, there was no evidence of bladder cancer in any of the studied groups, (p=not significant) which was also evident among 1111 patients on Pioglitazone therapy with a cumulative dose consumption of 2737 mg to 1,31,400 mg. On subgroup analysis, there was no evidence of bladder cancer amongst patients with age >60 years, duration of diabetes > 10 years and uncontrolled diabetics (HbA1c >8%) with cumulative pioglitazone consumption of >28,000 mg. A significant number of patients achieved good glycemic control (HbA1c <7.5%) with pioglitazone therapy.
Pioglitazone therapy was not associated with occurrence of bladder cancer among Indian type 2 diabetic patients and demonstrated good glycemic control.
确定吡格列酮是否会增加印度2型糖尿病患者患膀胱癌的风险。
对2222例2型糖尿病患者进行回顾性数据分析。研究对象分为两组，每组1111例：1111例吡格列酮使用者和1111例非吡格列酮使用者。从膀胱癌和其他类型癌症的发生情况分析吡格列酮治疗的安全性，并从血糖控制方面分析其疗效。评估安全性的参数包括疾病持续时间、使用时间、各年龄组吡格列酮的总服用剂量、血糖控制情况、肥胖情况以及任何癌症的家族史。基于尿细胞学、尿常规和显微镜检查、血尿、尿核基质蛋白22分析以及超声检查分析膀胱癌患病率。
在分析的2222例病例中，任何研究组均未发现膀胱癌证据（p=无统计学意义），这在1111例接受吡格列酮治疗、累积剂量为2737毫克至131400毫克的患者中也很明显。亚组分析显示，年龄>60岁、糖尿病病程>10年且血糖未得到控制（糖化血红蛋白>8%）且吡格列酮累积服用量>28000毫克的患者中，没有膀胱癌证据。大量患者通过吡格列酮治疗实现了良好的血糖控制（糖化血红蛋白<7.5%）。
吡格列酮治疗与印度2型糖尿病患者膀胱癌的发生无关，并显示出良好的血糖控制效果。
